In-depth implementation of the Vaccine Management Law to ensure public health

On June 29, 2019, the 11th meeting of the Standing Committee of the 13th National People’s Congress passed the "People’s Republic of China Vaccine Management Law".
On the same day, President Xi Jinping signed the 30th Presidential Order and promulgated it since December 1, 2019.
From implementation
.
The Vaccine Management Law stipulates the entire chain of vaccine development, production, circulation, vaccination, and supervision, and puts vaccine-related activities into the track of the rule of law
.
Soon after the promulgation and implementation of the Vaccine Management Law, the outbreak of the new crown pneumonia epidemic and the global public health crisis encountered a crisis.
In responding to the epidemic and crisis, people have further deepened their understanding of the function and role of vaccines, and have high hopes for the use of vaccines to defeat the epidemic.
The value of the legislation of the Vaccine Management Law And the significance is further demonstrated, and the relevant system norms have been further tested and played an important role in the anti-epidemic practice
.
The Party Central Committee with Comrade Xi Jinping as the core attaches great importance to the important role of vaccines in preventing and controlling the new crown pneumonia epidemic, safeguarding people's health and public health safety, and promoting the development, production, supply, and vaccination of the new crown pneumonia vaccine in accordance with the law, and has made significant progress.
A number of new coronary pneumonia vaccines have been listed conditionally
.
At present, our country is advancing the new coronary pneumonia vaccination work in an all-round and orderly manner
.
On this occasion, it is necessary to further understand and grasp the important significance, main content and spirit of the Vaccine Management Law, to further promote its implementation, and to add the rule of law to the fight against the epidemic
.
1.
The significance of the promulgation and implementation of the Vaccine Management Law Vaccines are preventive biological products used for human immunization to prevent and control the occurrence and prevalence of diseases.
It is a great invention produced in the process of human struggle against diseases
.
As the first comprehensive vaccine law in the world that provides comprehensive and systematic regulations on vaccine management, China's Vaccine Management Law is of great significance to its promulgation and implementation
.
The first is to implement the major measures of the Party Central Committee with Comrade Xi Jinping as the core on strengthening vaccine management and safeguarding the health of the people
.
General Secretary Xi Jinping attaches great importance to vaccine management and requires the use of the most rigorous standards, the most stringent supervision, the most severe penalties, and the most serious accountability to accelerate the establishment of a scientific and complete food and drug safety governance system
.
After the case of the Jilin Changchun Changsheng Company's vaccine problem occurred in 2018, General Secretary Xi Jinping issued important instructions many times, requiring a thorough investigation, serious accountability, and strict handling in accordance with the law, speeding up the improvement of the long-term vaccine drug supervision mechanism, and improving the laws, regulations and system rules.
; Emphasize the need to always put the health of the people in the first place, use strong medicine to eliminate irritation, scrape bones and treat drugs, improve China’s vaccine management system, resolutely maintain the bottom line of safety, and make every effort to protect the vital interests of the people and the overall situation of social security and stability
.
In September 2018, General Secretary Xi Jinping presided over the fourth meeting of the Central Comprehensive Deepening Reform Committee to deliberate and approve the "Opinions on Reforming and Improving the Vaccine Management System", requesting that relevant laws and regulations be improved as soon as possible
.
In order to implement the spirit of General Secretary Jinping’s important instructions and the Party Central Committee’s decision-making and deployment, the Standing Committee of the National People’s Congress gave full play to its leading role in legislation, strengthened communication and coordination with relevant departments, promoted the establishment of a vaccine management law drafting working group, and promoted the legislation of the vaccine management law with high quality and efficiency.
Work, in more than half a year, successfully completed this important legislative task, creating the "extra-fast" speed of legislation
.
The Vaccine Management Law implements the spirit of General Secretary Jinping’s important instructions on vaccine management and the Party Central Committee’s major decisions and deployments on reforming and improving the vaccine management system, establishing and improving a scientific and standardized vaccine management system.
There are many innovations and developments that are conducive to long-term adherence.
, Universal compliance
.
The second is to provide a strong guarantee for the implementation of the Healthy China strategy and the improvement of the people's health
.
General Secretary Xi Jinping emphasized that people's health is the foundation of social civilization and progress, an important symbol of national prosperity and national prosperity, and the common pursuit of the broad masses of people
.
Vaccines are an important guarantee for safeguarding people’s health, and they are the most direct and practical interests of the people
.
Infectious diseases are a major threat to human health.
Throughout the history of human development, vaccines have played an important role in the prevention and control of infectious diseases and the maintenance of people's health
.
For example, humans’ victory over and ultimately elimination of the ancient smallpox disease is inseparable from vaccine innovation and development.

.
In the mid-Ming Dynasty, the "human pox" vaccination technique to prevent smallpox appeared in our country; at the end of the 18th century, British scientist Edward Jenner invented a method of vaccination against smallpox; after the unremitting efforts of several generations of scientists, a vaccine to inactivate smallpox virus was finally developed
.
Through vaccination, smallpox was eventually eliminated
.
China is committed to safeguarding the health of the people, putting the people's health in a strategic position as a priority for development, and advancing the construction of a healthy China
.
The state establishes a system for the prevention and control of infectious diseases, insists on focusing on prevention, implements a vaccination system, strengthens immunization planning, and provides residents with free immunization planning vaccines
.
China is one of the few countries in the world that can provide all immunization programs with its own capabilities
.
In view of the characteristics and outstanding problems of vaccine management, the Vaccine Management Law integrates the relevant provisions of existing laws and administrative regulations, and according to the development needs and practical conditions of the situation, the vaccine management has been targeted, systematic, forward-looking and operable.
Strong regulations, ensuring vaccine safety throughout the entire process and the entire chain, and ensuring vaccine research and development, production, supply, and vaccination will surely promote the construction of a healthy China
.
The third is to provide a strong legal guarantee for responding to public health emergencies and preventing and controlling new emergent major infectious diseases
.
Preventing and resolving major risks such as major epidemics and sudden public health risks are related to national security and development, as well as to the overall social and political stability
.
In January 2018, General Secretary Xi Jinping enumerated 16 risks in 8 aspects at the opening ceremony of the seminar on studying and implementing the spirit of the 19th National Congress of the Communist Party of China.
Among them, he mentioned in particular, "Major infectious diseases like SARS need to be kept at all times.
Stay vigilant and take strict precautions
.
" The Vaccine Management Law adheres to the bottom line thinking, and has made forward-looking institutional arrangements for the development and management of vaccines urgently needed for public health emergencies and the prevention and control of new and major infectious diseases.

.
Under the strong leadership of the Party Central Committee with Comrade Xi Jinping as the core, China's new crown pneumonia vaccine research and development work is progressing smoothly, and it has always been the world's first phalanx.
It has adopted multiple technical routes such as inactivated vaccines, adenovirus vector vaccines, and recombinant protein vaccines to advance at the same time.
, A variety of candidate vaccines entered clinical trials, and many vaccines received conditional approvals.
The World Health Organization approved two Chinese vaccines to be included in the emergency use list, actively and steadily promoting the universal vaccination of new coronary pneumonia vaccines.
The Vaccine Management Law provides direct and specific details.
Legal support and protection
.
The fourth is to provide systemic institutional guarantees for strict vaccine management, improvement of vaccine quality, and utilization of the important role of vaccines in disease prevention and control
.
Since the founding of New China, especially since the reform and opening up, China’s immunization program has achieved remarkable results and made great contributions to disease prevention and control
.
At the same time, we must be soberly aware that problematic vaccine incidents have occurred from time to time during a period of time, exposing that the main responsibility is not fulfilled, the vaccination is not standardized, the innovation motivation is insufficient, the protection is insufficient, the supervision is not in place, the supervision ability is weak, and the cost of illegality is exposed.
Low-level outstanding issues
.
Especially after the Changchun Changsheng Company's vaccine case occurred, it has aroused public doubts and worries about the vaccine
.
The Vaccine Management Law adheres to the system concept, coordinating the development of the vaccine business and the bottom line of vaccine safety, not only based on the time, using the rule of law thinking and method to solve the deep-seated problems faced by vaccine management, but also focusing on the long-term, building the foundation of the rule of law, the strength of the rule of law, and the accumulation of The rule of law promotes a more mature and finalized vaccine management system, and provides long-term institutional guarantees for the healthy development of the vaccine industry and adherence to the bottom line of vaccine safety
.
The Vaccine Management Law takes "strengthening vaccine management, ensuring vaccine quality and supply, standardizing vaccination, promoting the development of the vaccine industry, protecting public health, and maintaining public health safety" as its legislative purpose, emphasizing that the country implements the most stringent management system for vaccines and adheres to safety First, risk management, full-process management and control, scientific supervision, and social co-governance, clarify the positioning of vaccine products as strategic and public welfare products, and create a good institutional environment for vaccine development
.
Vaccine management legislation reflects the great importance of the party and the state on vaccine safety and the lives and health of the people, reflects the strong determination of legal measures to strengthen vaccine safety defenses, responds to the people’s expectations for vaccine safety, and reshapes the society’s expectations for vaccine safety.
Confidence in vaccine safety will definitely promote the development of the vaccine industry
.
At present, vaccines, especially the new crown pneumonia vaccine, have become an important tool for competition and game among major powers and a powerful weapon to defeat the new crown pneumonia epidemic.
China has announced that the new crown pneumonia vaccine will be an important international public product, and China's vaccine management law has become the world's first comprehensive vaccine management Sexual laws are groundbreaking and pioneering, have a leading role in the world's vaccine management system, and contribute Chinese wisdom
.
2.
Encourage innovation and strengthen research and development Since the founding of New China, especially since the reform and opening up, China's vaccine industry has developed rapidly.
There are more than 40 vaccine manufacturers that can produce more than 60 vaccines and prevent more than 30 diseases.
It has become a major vaccine producer; However, China's vaccines are large but not strong as a whole, and the motivation for innovation is insufficient, and there is still a long way to go from the "vaccine power"
.
Strengthening vaccine research and development innovation is a major decision and deployment made by the Party Central Committee
.
General Secretary Xi Jinping emphasized that we must concentrate our efforts on key core technologies to solve the problem of "stuck necks" in a number of fields such as drugs, medical devices, and vaccines
.
The Vaccine Management Law has made a series of institutional arrangements around encouraging innovation and strengthening research and development
.
The first is to improve policy planning and establish clear guidance
.
The general provisions clearly stipulate that the state supports basic research and applied research of vaccines, promotes vaccine development and innovation, and incorporates the development, production, and storage of vaccines for the prevention and control of major diseases into national strategies
.
The state formulates development plans and industrial policies for the vaccine industry, supports industrial development and structural optimization, encourages large-scale and intensified production, and continuously improves vaccine production technology and quality levels
.
The second is demand-led and active support
.
It is clear that the country shall formulate relevant research and development plans according to the epidemic situation of the disease, the immune status of the population and other factors, arrange the necessary funds, and support the development of new vaccines such as multi-linkage and multi-valence.

.
Multi-linked vaccines are a combination of two or more antigens of different pathogens to prevent and control a variety of diseases
.
Multivalent vaccines are vaccines that mix two or more groups or types of antigens of the same pathogen to prevent and control diseases caused by infections of different groups or types of the same pathogen
.
Multi-linked multivalent vaccines are conducive to reducing the frequency of vaccination, expanding the protective effect of immunity, reducing the cost of vaccination and the risk of abnormal reactions.
It is the focus of encouragement and support by the state
.
In addition to multi-linked multivalent vaccines, new vaccines also include innovative vaccines for diseases without effective prevention and control methods, and vaccines produced using new strains of bacteria
.
The formulation of vaccine-related research and development plans by the state is conducive to clarifying the direction and focus of vaccine research and innovation, and improving the accuracy of vaccine research and innovation
.
The third is to promote vaccine marketing license holders to strengthen innovation and development
.
The state encourages vaccine marketing license holders to increase investment in research and innovation, optimize production processes, improve quality control, and promote vaccine technology progress
.
Vaccine marketing license holders shall establish and improve the quality management system for the whole life cycle of vaccines, and carry out post-marketing evaluation, post-marketing research, and post-marketing management of vaccines in accordance with regulations, so as to further improve the safety, effectiveness and quality controllability of vaccines To confirm, establish a vaccine quality review analysis and risk report system, conduct quality tracking analysis of vaccines, continuously improve quality control standards, improve production processes, and increase production process stability
.
Vaccine marketing license holders are enterprises that have obtained vaccine drug registration certificates and drug production licenses in accordance with the law.
They should strengthen the quality management of the entire life cycle of vaccines and be responsible for the safety, effectiveness and quality controllability of vaccines
.
During the legislative process, in-depth discussions were held on whether to implement a marketing authorization holder system in the field of vaccines
.
Some have suggested that vaccine marketing license holders are different from general drug marketing license holders and require that they must have production capacity.
In fact, they are required to be vaccine manufacturers, and generally they are not allowed to commission production.
Drug marketing license holders The scope of the pilot program also does not include vaccines, and it is recommended not to implement the vaccine marketing authorization holder system; some suggest that it is necessary to implement the vaccine marketing authorization holder system, but it must be clear that the vaccine marketing authorization holder obtains the drug production license Enterprises to distinguish general drug marketing authorization holders
.
After in-depth research, the holder of the vaccine marketing authorization required by the law is different from the drug marketing authorization holder, and must be an enterprise that has obtained both the vaccine drug registration certificate and the drug production license
.
Establishing a vaccine marketing license holder system in the law is conducive to ensuring the sustainable and sound development of vaccine research, production, and supply; it is conducive to clarifying and implementing the legal responsibilities of all participants in the vaccine life cycle, and strengthening vaccine marketing The main responsibility of the license holder for the quality of the vaccine; it is conducive to the formation of a whole-process and full-chain supervision model centered on the vaccine marketing license holder, and improves the effectiveness of vaccine supervision; guarantees that vaccine developers can maximize the enjoyment of the results brought by innovation.
It is helpful to stimulate the innovation enthusiasm of vaccine developers and promote vaccine research and innovation
.
The fourth is to encourage clinical trials to provide favorable conditions for innovative research and development
.
Clinical trials are trials on humans (patients or healthy subjects), intended to discover or verify the clinical medicine, pharmacology, and other pharmacodynamic effects, adverse reactions, or absorption and distribution of a test drug , Metabolism and excretion to determine the efficacy and safety of the drug systemic trials
.
Clinical trials are an important part of the vaccine development process.
The Vaccine Management Law covers clinical trials of vaccines in terms of clinical trial approval, trial institutions, trial protocols, trial safety monitoring and evaluation, informed consent, and protection of the legitimate rights and interests of subjects.
Norms
.
In practice, the number of qualified vaccine clinical trial institutions is small, and their own business is generally heavy.
There is a problem that the enthusiasm for conducting vaccine clinical trials is not high.
Therefore, the law stipulates that the state encourages qualified medical institutions, disease control institutions, etc.
to carry out legally.
Vaccine clinical trials
.
In addition, the Vaccine Management Law also forces the development and innovation of vaccines through systems such as post-marketing management and selective elimination.

.
For example, if it is clear that a vaccine that has a severe abnormal response to vaccination or that is harmful to human health for other reasons, the State Food and Drug Administration should cancel the drug registration certificate of the vaccine
.
If the product design, production process, safety, effectiveness or quality controllability of a vaccine variety is found to be significantly inferior to other vaccine varieties for the prevention and control of the same disease after the post-marketing evaluation, the drug registration certificate of all vaccines of that variety should be cancelled and Abolish the corresponding national drug standards
.
3.
Combination of peace and emergency and meeting urgent needs Vaccines are a strategic product for disease prevention and control.
Vaccination is not only the basic work of disease prevention and control in ordinary times, but also a powerful weapon to deal with major outbreaks of infectious diseases.
We must adhere to the combination of peace and emergency.
Satisfy urgent needs and ensure that they are available at critical moments
.
The Vaccine Management Law has made overall arrangements to alleviate urgent needs and made relevant institutional arrangements
.
The first is to strengthen the organization and jointly tackle key problems
.
The long-term vaccine development cycle and large investment require strong support from the state
.
The Vaccine Management Law requires the state to organize vaccine marketing license holders, scientific research units, and medical and health institutions to jointly tackle key problems and develop vaccines that are urgently needed for disease prevention and control
.
After the outbreak of the new crown pneumonia, 12 departments including the Ministry of Science and Technology, the National Health Commission, and the State Food and Drug Administration formed a scientific research team for the joint prevention and control mechanism of the State Council in accordance with the law.
In the most important position, organize relevant vaccine research and development companies, scientific research units, medical institutions, disease control institutions, and laboratory animal research institutions to jointly tackle key problems, and simultaneously promote inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, and attenuated influenza There are 5 technical routes for virus vector vaccines and nucleic acid vaccines
.
The second is the priority review and approval system, which clarifies vaccines and innovative vaccines that are urgently needed for disease prevention and control, and the State Food and Drug Administration should give priority review, review and approval
.
During the development and marketing of new coronavirus pneumonia vaccines such as the conditional listing of the new coronavirus inactivated vaccine of Sinopharm Beijing Company, the Drug Evaluation Center of the State Drug Administration issued 5 guidelines including the "Guidelines for Clinical Evaluation of New Coronavirus Preventive Vaccines (Trial)" In principle, the State Food and Drug Administration gave priority review and approval in accordance with the law, speeding up the development and marketing of the new coronary pneumonia vaccine
.
The third is a conditional approval system, which clarifies that vaccines that are urgently needed in response to major public health emergencies or other vaccines that are urgently needed by the National Health Commission have been assessed that the benefits outweigh the risks, and the State Food and Drug Administration may conditionally approve vaccine registration applications
.
For vaccines that require further research during the approval of the vaccine registration application, the vaccine marketing license holder shall complete the research within the prescribed time limit; if the research is not completed within the specified time period or cannot be proved that the benefits outweigh the risks, the State Food and Drug Administration shall deal with it in accordance with the law until Cancel the drug registration certificate of the vaccine
.
On December 23, 2020, on the basis of the preliminary rolling submission of research data, Sinopharm Zhongsheng Beijing Company formally submitted a conditional listing application for the registration of a new coronavirus inactivated vaccine, which has undergone strict review, review, verification, inspection and data analysis, etc.
A series of statutory procedures evaluated and determined that the known and potential benefits of Sinopharm Beijing’s new coronavirus inactivated vaccine outweigh the known and potential risks, and fully met the pre-set conditional listing requirements, taking the new crown pneumonia epidemic into consideration.
Factors such as the global epidemic and there is no specific drug for the treatment of new coronary pneumonia in the world.
On December 30, 2020, the State Food and Drug Administration approved the conditional listing application for the conditional listing of the new coronavirus inactivated vaccine of Sinopharm Zhongsheng Beijing Company and submitted it.
Specific conditional post-marketing research requirements
.
The fourth is the emergency use system.
It is clear that there are particularly major public health emergencies or other emergencies that seriously threaten public health.
The National Health Commission puts forward recommendations for emergency use of vaccines based on the needs of infectious disease prevention and control, which are organized by the State Food and Drug Administration.
After consent, it can be used urgently within a certain range and time limit
.
After a series of rigorous demonstrations, reviews and other legal procedures, in June 2020, the "New Coronavirus Vaccine Emergency Use Plan" was approved in accordance with the law.
Under the premise of monitoring of adverse reactions and preparations for emergency treatment, emergency vaccination of new coronary pneumonia vaccine was carried out for high-risk groups
.
The emergency vaccine is a vaccine that has completed animal trials, phase I clinical trials, and phase II clinical trials in strict accordance with relevant regulations, and has achieved very good safety indicators and immunogenicity indicators in phase I and II clinical trials.

.
The fifth is to guarantee the production and supply system, clarify that the Ministry of Industry and Information Technology, the Ministry of Finance, in conjunction with the National Health Commission, the Ministry of Public Security, the State Administration of Market Supervision, and the State Drug Administration, should strengthen the production capacity of vaccine reserves in accordance with the needs of disease prevention, control and public health emergency preparedness.
Product management, establish a dynamic adjustment mechanism
.
In the event of an outbreak or epidemic of infectious diseases, the relevant vaccine marketing license holders should promptly produce and supply vaccines for the prevention and control of infectious diseases; transportation units should give priority to the transportation of vaccines for the prevention and control of infectious diseases; governments at or above the county level and relevant departments should do so Good organization, coordination and guarantee work
.
Since the outbreak of the new crown pneumonia, the Ministry of Industry and Information Technology and other relevant parties have strengthened production scheduling in accordance with the law, accelerated production capacity construction, ensured the smooth flow of vaccine production and supply chains, and did a good job in the production organization and guarantee of the new crown pneumonia vaccine.
As of the end of 2020, 18 companies have Pneumonia vaccine research and development progress, and production capacity construction has been successively carried out.
Sinopharm Zhongsheng Beijing Company, Sinopharm Zhongsheng Wuhan Company, and Beijing Kexing Zhongwei Company have completed capacity expansion on the basis of completing the 2020 production capacity construction task.
Sinopharm Zhongsheng Beijing The company and other companies have launched large-scale production of new coronary pneumonia vaccines, laying the foundation for meeting the domestic demand for large-scale vaccination of new coronary pneumonia vaccines
.
At the same time, Chinese enterprises have also fully considered meeting overseas demand
.
The sixth is to establish a system for exempting batches and issuance under special circumstances
.
Vaccines that are urgently needed to prevent and control infectious diseases or respond to emergencies are approved by the State Food and Drug Administration and are exempted from approval to ensure emergency needs; group vaccinations and emergency emergencies in a certain area during outbreaks and epidemics of infectious diseases Inoculation and other systems have been arranged to effectively respond to and control major outbreaks of infectious diseases
.
In addition, the usual management systems for vaccine distribution and vaccination will be used in emergency situations with stricter standards
.
Many systems in the Vaccine Management Law are applicable to both normal and emergency situations
.
For example, preventive vaccination systems such as the verification of vaccination taboos, the "Notice on Further Doing a Good Job in the Prevention and Control of the New Coronary Pneumonia Epidemic in Winter and Spring" requires that vaccination be carried out in strict accordance with the regulations of the Vaccine Management Law, the Vaccination Work Regulations, and strict implementation of health inquiries, Vaccination taboo verification, informed notification, information registration, "three checks and seven to one verification", observation after vaccination and other procedures, and prepare for suspected abnormal reaction monitoring and disposal as required
.
The new crown pneumonia epidemic is the most serious infectious disease pandemic that has occurred in the world in a century.
It is a major public health emergency with the fastest spread, the widest range of infections, and the most difficult prevention and control that China has encountered since the founding of the People’s Republic of China.
There is an urgent need for vaccines.
The prevention and control of the new crown pneumonia epidemic provides strong support
.
Our country adheres to the people's supremacy and life supremacy.
It takes the advantages of the new nationwide system to take the lead in developing a vaccine for the new crown pneumonia, providing a powerful weapon for the prevention and control of the epidemic
.
The Vaccine Management Law insists on meeting emergency needs, provides a strong guarantee for the overall promotion of the development, production, supply, and vaccination of the new crown pneumonia vaccine on the track of the rule of law, and has made positive contributions to the overall promotion of epidemic prevention and control and economic and social development
.
4.
Strict production to ensure quality Vaccines are produced, and strict production is an important guarantee for vaccine quality
.
The Changchun Changsheng Company’s vaccine case is a major case of vaccine manufacturers’ violation of the law, violation of national drug standards and drug production quality management regulations, and fabricating false production inspection records.
It reflects the systemic flaws in vaccine production
.
In response to the outstanding problems in the production of vaccines in the past, summing up practical experience, the Vaccine Management Law has further tightened the production management system
.
One is strict production access
.
It is clarified that the country implements a strict access system for vaccine production.
To engage in vaccine production activities must meet the corresponding conditions and be approved by the drug regulatory department at or above the provincial level to obtain a drug production license
.
Vaccines are drugs.
To engage in vaccine production activities must first meet the conditions for engaging in pharmaceutical production activities stipulated by the Drug Administration Law
.
For example, there are legally qualified pharmaceutical technicians, factories suitable for pharmaceutical production, etc.

.
At the same time, as a special medicine, vaccine production activities must meet the following conditions: Have a moderate scale and sufficient production capacity reserves
.
Under normal circumstances and in emergencies such as public health emergencies, the demand for vaccines changes greatly.
Guaranteeing vaccine supply in emergencies requires companies to be able to urgently expand production and have sufficient capacity reserves
.
Have systems, facilities and equipment to ensure biosafety
.
Vaccines are autoimmune preparations that use pathogenic microorganisms and their metabolites through artificial attenuation, inactivation or genetic engineering methods to prevent and control diseases
.
Viruses and bacteria are the main starting materials for vaccines, and there are biological safety risks in vaccine development, production, and inspection processes
.
The Vaccine Management Law specifically stipulates that in the process of vaccine development, production, and inspection, a sound biosafety management system should be established to strictly control biosafety risks, strengthen biosafety management of pathogenic microorganisms such as bacterial strains, and protect the health of operators and the public , To ensure that the use of pathogenic microorganisms such as bacterial strains is legal and legitimate
.
Bacterial strains and cell strains used in vaccine development, production, testing, etc.
should be clearly defined in history, biological characteristics, and generations, and detailed files should be established to ensure that the source is legal, clear, and traceable.
The source is not clear, and shall not be used
.
In October 2020, China enacted a biosafety law to strengthen the biosafety system, which clearly stipulates that the biosafety management of production workshops involving pathogenic microorganisms shall be carried out in accordance with the regulations on pathogenic microorganism laboratories and other biosafety management regulations.

.
Meet the needs of disease prevention and control
.
China’s vaccine industry has problems such as low concentration and serious homogeneity competition.
Some vaccines are produced by multiple companies, and many companies only produce one vaccine.
A benign industry ecology has not yet been fully established
.
It is necessary to expand and strengthen China's vaccine industry in accordance with domestic and foreign disease prevention and control needs
.
Whether the vaccine can be commissioned for production is an important issue studied in the legislative process
.
The draft of the Vaccine Management Law stipulates that vaccines shall not be commissioned for production, unless otherwise specified by the State Drug Administration
.
During the review and revision process, some proposed that the commissioning of vaccine production is a relatively common practice in the world.
From the perspective of the development of the vaccine industry, in order to improve the quality and efficiency of vaccine production, commissioned production should be allowed, and the conditions and approval of vaccine commissioned production should be made.
Regulations, while strengthening the supervision of commissioned production enterprises
.
Some have also proposed that the "Regulations on the Implementation of the Drug Administration Law" (currently under study and revision) clearly stipulates that vaccines shall not be commissioned.
The problematic vaccine incidents that have occurred in the past are also related to commissioned production.
Further strict management of vaccine production should be made, and vaccines must not be commissioned.
Production
.
After research, it is indeed necessary to commission production in some situations in practice
.
For example, China's joint vaccine R&D and production capacity is still relatively weak.
When producing joint vaccines, entrusting other companies to produce some antigens can improve the quality and efficiency of joint vaccine production
.
Therefore, the law stipulates that if the production capacity exceeds the vaccine production capacity, it should be approved by the State Drug Administration; if the production is entrusted, it should comply with the provisions of this law and relevant national regulations to ensure the quality of the vaccine
.
The Vaccine Management Law provides the basis and norms for the commissioned production of vaccines
.
The second is to strictly control the entire production process
.
Vaccines, as biological products, have complex composition and properties.
Compared with general drugs, the entire process of vaccine production requires stricter and stricter control
.
First, the vaccine must be produced and tested in accordance with the approved production process and quality control standards
.
The holder of the vaccine marketing authorization shall review and inspect the entire production process of the vaccine and the quality of the vaccine in accordance with the regulations
.
Vaccine production technology and quality control standards are important documents to ensure vaccine quality and an important basis for vaccine production and inspection
.
When the State Food and Drug Administration approves the vaccine registration application, it shall approve the production process and quality control standards of the vaccine
.
Changes in the production process shall be evaluated and verified, and shall be filed or reported in accordance with the "Measures for Post-Marketing Change Management (Trial)" and other regulations of the State Food and Drug Administration; the changes may affect the safety, effectiveness and quality of the vaccine If it is controllable, it shall be approved by the State Food and Drug Administration
.
Change management is the focus of all aspects in the legislative process
.
The Drug Administration Law before revision in 2019 once stipulated that if a drug manufacturer changes the production process that affects the quality of the drug, it must report to the original approval department for review and approval
.
In practice, it is more strongly reflected that it is difficult for manufacturers to accurately grasp which changes are affecting quality, which results in the implementation of this regulation is not in place
.
The Vaccine Management Law clearly implements classified management of changes and makes specific provisions
.
Secondly, the whole process of vaccine production should meet the requirements of Good Manufacturing Practice (GMP)
.
As a part of the quality management system, the pharmaceutical production quality management specification is the basic requirement of pharmaceutical production management and quality control.
It aims to minimize the risks of pollution, cross-contamination, confusion, and error in the pharmaceutical production process, and ensure continuous and stable production.
Drugs that meet the intended use and registration requirements
.
As a special medicine with biological activity, vaccines should meet the requirements of GMP in the whole production process; GMP "Biological Products" and other appendices also put forward some special requirements for vaccine production, and the whole process of vaccine production should also meet these requirements
.
Third, vaccine marketing license holders should establish a complete production quality management system, continue to strengthen deviation management, and use information technology to truthfully record all data formed during the production and inspection process
.
Any deviation from the production process, material balance limits, quality control standards, inspection methods, operating procedures, etc.
during the vaccine production process may affect the quality of the vaccine, and management should be strengthened
.
In addition, units and individuals engaged in vaccine development, production, circulation, and vaccination activities should ensure that the information throughout the entire process is true, accurate, complete and traceable
.
The country implements a vaccine full-process electronic traceability system, establishes a national vaccine electronic traceability coordination platform, integrates traceability information throughout the entire process of vaccine production, circulation, and vaccination, and realizes vaccine traceability
.
Vaccine marketing license holders should establish a vaccine electronic traceability system to link with the national vaccine electronic traceability collaborative platform to realize the traceability and verifiability of the smallest packaging unit vaccine in the whole process of production, circulation and vaccination
.
Disease control agencies and vaccination units shall truthfully record vaccine circulation, vaccination, etc.
according to law, and provide traceability information to the national vaccine electronic traceability collaboration platform as required
.
The supply and vaccination of the new crown pneumonia vaccine has been traceable in accordance with the regulations of the Vaccine Management Law
.
The third is to strictly manage the batch issuance of vaccines
.
Vaccine batch issuance is an activity by the State Food and Drug Administration for vaccines that have been approved for marketing, before each batch of products is marketed or imported, after review and inspection by the designated batch issuing agency, and issuance of certificates for batches that meet the requirements
.
The State Food and Drug Administration has designated the China National Inspection Institute and some provincial drug inspection agencies to jointly be responsible for the issuance of vaccine batches
.
Vaccine batch issuance is the last inspection pass before vaccine sales and the last line of defense to prevent vaccines with quality problems from entering the circulation link
.
The Vaccine Management Law clarifies that the country implements a vaccine batch issuance system; except for very special circumstances, each batch of vaccines should be sold or imported before a batch issuance certificate; vaccines that are not approved for batch are not allowed to be sold and should be handled in accordance with regulations
.
The fourth is to optimize the procurement and supply of vaccines
.
Vaccines include immunization schedule vaccines and non-immunization schedule vaccines
.
Immunization program vaccines are vaccines that residents should be vaccinated in accordance with government regulations, including vaccines determined by the national immunization program and other immunization program vaccines other than those of the national immunization program (including vaccines added by the provincial government during the implementation of the national immunization program, as well as county-level vaccines).
Vaccines used for emergency vaccination or group vaccination organized by the above government or its health department); non-immunization program vaccines are other vaccines voluntarily vaccinated by residents
.
The Vaccine Management Law stipulates that the National Health Commission and the Ministry of Finance shall organize centralized bidding or unified negotiation for vaccines in the National Immunization Program, and form and announce the winning bid or transaction price, and all provinces (autonomous regions, municipalities) shall implement unified procurement
.
All provinces (autonomous regions, municipalities) organize the procurement of other immunization program vaccines and non-immunization program vaccines other than the national immunization program vaccines through the provincial public resource trading platform
.
Vaccines are subject to market-adjusted prices, that is, operators independently set prices and form prices through market competition
.
The price of the vaccine is determined by the holder of the vaccine marketing license independently and reasonably according to law, and the price level, price difference and profit margin of the vaccine should be maintained at a reasonable range
.
Vaccine procurement involves both buyers and sellers.
The price set independently and reasonably by the vaccine marketing license holder is only the seller's quotation.
The final sales price of the vaccine (winning bid price, transaction price, etc.
) needs to be determined by both buyers and sellers
.
The most basic requirement is high quality and good price .
The production cycle of vaccines is generally relatively long, and some vaccines have a relatively short validity period, and the risk of vaccine shortages is relatively high.
During the legislative process, guaranteeing the supply of reserves is also one of the key issues concerned by all parties.
In order to strengthen vaccine reserves and effectively ensure the safety of vaccine supply, The Vaccine Management Law has improved relevant systems, including vaccines into strategic material reserves, and implements central and provincial-level reserves
.
Provincial disease control agencies should formulate vaccine use plans for immunization programs, including vaccine varieties, quantities, supply channels, and supply methods, and report and record them in accordance with regulations
.
The National Health Commission provides vaccine demand information according to the vaccine use plan of the National Immunization Program, and the vaccine marketing license holder arranges production according to the vaccine demand information; when there is a risk of shortage of vaccine supply, the National Health Commission and the State Food and Drug Administration make recommendations The Ministry of Industry and Information Technology and the Ministry of Finance shall take effective measures to ensure vaccine production and supply; vaccine marketing license holders shall organize production in accordance with the law to ensure vaccine supply.
If vaccine production is stopped, they shall promptly report to the drug regulatory authority
.
V.
Safe circulation and standardized vaccination (1) Interlocking, closed-loop operation of vaccines as special drugs, one of the important manifestations of its particularity is that the circulation of vaccines is different from general drugs, and even different from general biological products (for example, vaccine storage, Transportation has high requirements on the cold chain)
.
In 2016, in response to the series of cases of vaccine management in Shandong, South Africa and South Africa, the second-class vaccines had a long circulation chain and large profit-making space.
During the storage and transportation of the vaccine, the effectiveness of the vaccine was affected by the cold chain, and the vaccine traceability system was not perfect.
The State Council has focused on revising and improving the "Regulations on the Administration of Vaccine Circulation and Vaccinations" enacted in 2005 (after the implementation of the Vaccine Administration Law, repealed on March 27, 2020) regulations on the circulation of vaccines
.
In accordance with the "Opinions on Reforming and Improving the Vaccine Management System," the Vaccine Management Law adheres to the spirit of optimizing distribution and distribution, and insists on ensuring the safety of distribution and strict distribution systems
.
One is a tightly closed-loop supply chain
.
Vaccines are supplied by vaccine marketing license holders to disease control agencies, and then from disease control agencies to inoculation units.
This supply chain is one-way irreversible, which is conducive to reducing the risk of vaccine quality
.
Only the disease control agency can supply vaccines to the inoculation unit.
Units and individuals other than the disease control agency are not allowed to supply vaccines to the inoculation unit; the inoculation unit can only receive vaccines supplied by the disease control agency, and must not receive supplies from units and individuals other than the disease control agency.
Vaccine
.
The second is to strictly distribute vaccines
.
How to safely distribute vaccines is a matter of concern in the legislative process
.
The draft vaccine management law stipulates that vaccine marketing license holders distribute to disease control agencies, and the disease control agency organizes distribution to inoculation units; they can deliver them by themselves or entrust vaccine delivery units to deliver them
.
At that time, there were a variety of delivery methods in practice, some were production companies-disease control agencies-inoculation units, some were production companies-distribution companies-vaccination units, and some were directly distributed by the production companies to the vaccination units through disease control agencies
.
Some have suggested that since disease control agencies can entrust delivery companies to deliver vaccines to inoculation units, and production companies that have vaccine cold chain transportation capabilities, they should also be able to directly deliver vaccines to designated inoculation units under the organization of disease control agencies
.
After in-depth research, the law stipulates that vaccine marketing license holders can also distribute the vaccine to the inoculation unit designated by the disease control agency
.
Disease control agencies, inoculation units, vaccine marketing license holders, and vaccine delivery units must comply with vaccine storage and transportation management practices to ensure vaccine quality
.
The core requirement of the vaccine storage and transportation management standard is that the vaccine should be in the specified temperature environment during the whole process of storage and transportation.
The cold chain storage and transportation must meet the requirements, and the temperature should be monitored and recorded regularly
.
Disease control agencies, vaccination units, etc.
must establish and maintain distribution and other related records, obtain record certificates in accordance with the law, and establish a regular inspection system
.
(2) Regulate vaccination and keep it up.
Preventive vaccination is the implementation link of vaccine service to public health.

.
China's vaccination work has made major achievements, and the immunization program has a high vaccination rate, which has played an important role in building an immune barrier and protecting public health
.
At the same time, some problems have occurred in the vaccination link in the past, and they have been relatively concentrated for a period of time
.
Many vaccinations are aimed at minors, and the general public is concerned
.
In order to do a good job in vaccination, the Vaccine Management Law regulates related systems
.
One is to strengthen the immunization planning system
.
The immunization plan is the "planned immunization"
.
The Vaccine Management Law makes specific provisions on the immunization planning system
.
For example, it is clear that the national immunization plan is formulated by the National Health Commission.
The National Health Commission and the Ministry of Finance draft the national immunization plan vaccine types and establish a dynamic adjustment mechanism.
The national immunization plan vaccine types are announced after approval by the State Council, and the provincial government can increase the immunization plan.
Types of vaccines; the National Health Commission established the National Immunization Planning Expert Advisory Committee; in order to ensure the vaccination rate of the children's immunization program and strengthen the responsibility of guardians, it is stipulated that guardians should not guarantee timely vaccination of school-age children in accordance with the law, and the health department will criticize and educate them
.
The second is to clarify the conditions of the inoculation unit
.
Vaccination units refer to institutions that undertake the task of vaccination (including urban medical institutions, township health centers, community health service centers, etc.
), and must have the qualifications to obtain a medical institution's practice license and have qualified medical and health personnel
.
Vaccination units engaged in immunization planning vaccination work need to be designated by the local health department above the county level and clarify the area of ​​responsibility; qualified medical institutions engaged in non-immunization planning vaccination work must report to the relevant health department for the record
.
The third is to standardize vaccinations
.
It is clear that the vaccination unit should comply with the vaccination work specifications, immunization procedures, and vaccine use guidelines formulated by the National Health Commission and the vaccination plan formulated by the provincial health department
.
Disease control agencies at all levels should strengthen the technical guidance of vaccination units and the management of vaccine use
.
At the same time, in order to further regulate vaccination behavior, the Vaccine Management Law has made specific provisions on some important contents of vaccination work.

.
For example, prior to the implementation of vaccination, the relevant information should be informed and asked, and if necessary, medical advice should be given; before the implementation of the vaccination, the health status of the recipient should be checked, the vaccination contraindications should be checked, the vaccination certificate should be checked, and the appearance, batch number, and expiry date of the vaccine and syringe should be checked.
Check the name and age of the recipient and the product name, specification, dose, inoculation site, and route of inoculation; if the recipient has adverse reactions during the on-site observation period, timely treatment and other measures shall be taken; medical and health personnel shall be established in accordance with regulations Keep vaccination records to ensure that vaccination information can be traced and inquired
.
The state implements a vaccination certificate system for children.
The vaccination certificate shall be handled by the guardian at the vaccination unit or the birth hospital and kept properly
.
When children enter nursery or school, nursery institutions and schools should check the vaccination certificate, and if they find that they have not been vaccinated in accordance with the regulations, they should report and deal with them in accordance with the regulations
.
A small vaccination certificate affects the hearts of thousands of parents.
During the legislative process, the most prominent reflection is that the format is not uniform, which is not conducive to remote vaccination.
It is not convenient to apply for the certificate, and in some cases it is impossible to obtain the certificate
.
In response to these problems, the Vaccine Administration Law stipulates that birth hospitals can apply for vaccination certificates, and the people individually apply for vaccination certificates.
Vaccination units and birth hospitals shall not refuse to apply for vaccination certificates.
The format of vaccination certificates shall be adjusted by the regulations of various provinces (regions, cities).
Uniform regulations of the National Health Commission
.
(3) Improving the compensation system and removing concerns about vaccination.
Abnormal response to vaccination refers to drugs for which qualified vaccines cause damage to the tissues, organs, and functions of the recipient during or after the implementation of standardized vaccination, and no relevant parties are at fault.
Adverse reactions
.
General reactions, incidents, psychogenic reactions, and damage to the recipient due to vaccine quality problems are not considered abnormal reactions to vaccination
.
Due to the characteristics of the vaccine itself and the individual differences of the recipients, any vaccine will inevitably produce an abnormal response to vaccination.
Some people call it "the devil's lottery.
" Although the probability of an abnormal response to vaccination is extremely low, death or severe disability occurs.
The probability is lower, but for an individual, once an abnormal response to vaccination occurs, it is the bearer of the abnormal response and must be dealt with.

.
Properly handling the abnormal response of vaccination is related to the vital interests of the recipients and the smooth development of vaccination work, and is the focus of attention from all aspects in the legislative process
.
The core is the scope, standard and guarantee of compensation
.
According to opinions from various parties, the Vaccine Management Law mainly makes the following provisions in improving the system of compensation for abnormal reactions in vaccination: First, strengthen the monitoring and reporting of abnormal reactions in vaccination
.
Disease control institutions, vaccination units, medical institutions, vaccine marketing license holders, etc.
, should report suspected abnormal reactions to vaccination in accordance with the rules of vaccination work and the national suspected abnormal vaccination monitoring program
.
The second is to standardize the investigation, diagnosis and identification of abnormal reactions to vaccination
.
For suspected abnormal reactions to vaccination, the disease control agency shall organize investigations and diagnoses in accordance with regulations, and inform the recipients or their guardians of the conclusions; if there are disputes about the conclusions of the investigations or diagnosis, they may apply for identification; the death of the recipients due to vaccination , Severe disability, or group suspected abnormal response to vaccination, the health and health department and the drug regulatory department shall organize the investigation and handling in accordance with their respective duties and powers
.
The third is to improve the compensation for abnormal response of vaccination
.
The Vaccine Management Law stipulates that the state implements a compensation system for abnormal responses to vaccination, and clearly stipulates the scope of compensation, compensation funds, compensation principles, and supporting regulations
.
1.
Regarding the compensation range
.
Compensation will be given to the recipient for "death, severe disability, organ and tissue damage, etc.
" due to an abnormal response to vaccination; the above-mentioned damage cannot be ruled out due to an abnormal response to vaccination, and compensation is also given
.
This is an important development of the Vaccine Management Law to the compensation system for abnormal reactions
.
In practice, after investigation, diagnosis, and identification of suspected abnormal vaccination reactions, some can be clearly identified as abnormal vaccination reactions, some can be ruled out as abnormal vaccination reactions, and some can neither be clear nor ruled out
.
Some countries and regions also provide compensation for those that cannot be clarified or ruled out.
During the legislative process, it is learned that some provinces and cities in my country will include circumstances that cannot be ruled out.
The Vaccine Management Law affirms this.

.
At the same time, clarify the scope of compensation and implement catalog management, and make dynamic adjustments based on actual conditions
.
The scope of compensation is managed by catalogue to make the scope of compensation clearer, easier to operate, and to reduce unnecessary disputes
.
After the scope of compensation is managed by the catalog, if the damage is not in the catalog, but it can be proved that there is a causal relationship between the damage and the vaccination, compensation should also be given
.
The "Reference Catalogue and Instructions for Compensation Range of Abnormal Vaccination Reactions (2020 Edition)" stipulates that after a suspected abnormal reaction of vaccination occurs, in the process of investigation, diagnosis or identification of abnormal vaccination reaction, in addition to referring to this catalog, it must be combined with clinical practice.
To determine whether an abnormal response to vaccination belongs to or cannot be ruled out with related materials such as laboratories, and whether it is within the scope of this catalog should not be used as a direct basis for determining whether an abnormal response to vaccination is or cannot be ruled out
.
2.
Regarding compensation funds
.
Compensation costs for the vaccination program vaccination shall be "arranged in the vaccination funds" by the provincial finance department
.
Compensation costs for vaccination of non-immunization program vaccines shall be borne by the relevant vaccine marketing license holders
.
The state encourages the use of commercial insurance and other forms to compensate recipients of abnormal reactions to vaccination
.
3.
On the principle of compensation
.
In view of the problems in practice that the compensation is not timely enough, the procedure is not simple enough, and the standard is not reasonable enough, it is clear that the compensation for abnormal response of vaccination should be timely, convenient and reasonable
.
4.
Regarding supporting regulations
.
Compensation for abnormal response to vaccination is a very complicated issue.
The law can only provide in principle.
The scope, standards, and procedures of compensation are stipulated by the State Council, and provinces (regions, cities) formulate specific implementation measures
.
VI.
Clarify responsibilities and increase penalties (1) Clarify responsibilities and plug loopholes In order to ensure that units engaged in vaccine production, distribution, and vaccination activities strictly perform their main responsibilities, the government and relevant departments must strictly supervise them
.
The Changchun Changsheng Company's vaccine case and other issues exposed many loopholes such as inadequate vaccine supervision
.
In order to resolutely plug the loopholes in supervision, in accordance with the decision and deployment of the Party Central Committee, strengthen supervision and control the outstanding problems in vaccine supervision, the Vaccine Management Law has improved and innovated the supervision system
.
One is to strengthen organization and coordination at the government level
.
Governments above the county level should strengthen vaccine regulatory capacity building, establish and improve the supervision mechanism vaccine; develop vaccine safety emergency response plan, specific vaccine safety event classification and disposal command structure and responsibilities, preventive early warning mechanism, handling procedures, emergency safeguard measures
.
Local governments at or above the county level are responsible for the supervision of vaccines in their respective administrative regions, and lead, organize, and coordinate the supervision of vaccines in their respective administrative regions, including emergency response work
.
The State Council and provincial governments have established a departmental coordination mechanism to coordinate the work of vaccine supervision, regularly analyze the vaccine safety situation, strengthen vaccine supervision, and ensure vaccine supply
.
The second is to strengthen the supervision responsibility of the competent department
.
The drug regulatory department is responsible for the supervision of vaccines, the health department is responsible for the supervision of vaccination, and other relevant departments are responsible for the supervision of vaccines within the scope of their respective duties
.
The drug regulatory department and the health department supervise the entire process of vaccine development, production, circulation, and vaccination in accordance with their respective responsibilities
.
The drug supervision department shall supervise and inspect the quality of vaccines in vaccine development, production, storage, transportation and vaccination according to law; the health and health department shall supervise and inspect the implementation of the immunization planning system and vaccination activities in accordance with the law
.
The drug regulatory department focuses on on-site inspections of vaccine marketing license holders; if necessary, extended inspections can be carried out
.
Drug regulatory departments, health and health departments, vaccine marketing license holders, disease control agencies, vaccination units, medical institutions, etc.
, should work together to report on vaccine safety incidents, medical treatment, risk control, investigation and processing, information release, and explanations.
, Aftermath disposal and other work
.
The state builds a team of drug inspectors at the central and provincial levels to strengthen the supervision and inspection of vaccines
.
Provincial-level drug regulatory authorities select inspectors to be stationed in vaccine marketing license holders
.
Inspectors are responsible for supervising and inspecting the implementation of GMP, collecting vaccine quality risks and clues on violations of laws and regulations, reporting the situation to the dispatching department and making suggestions, and be responsible for the behavior during the dispatch period
.
The "Opinions on Establishing a Team of Professional and Specialized Drug Inspectors" has made specific provisions on improving the drug inspection system and mechanism, implementing the deployment of inspectors, and strengthening the management of the inspector team
.
The third is to strengthen supervision methods
.
The Administrative Punishment Law, the Administrative Mandatory Law, and the Administrative Licensing Law have clear provisions on the authority to set penalties, compulsions, and licenses.
If some regulatory methods are not set by law, regulations and rules have no right to set them.
This is also a special legislation for vaccine management.
Important considerations
.
The Vaccine Management Law has enriched and improved the regulatory methods that the drug regulatory department, health and health department and other departments can take, including interviews, ordering the suspension of vaccine production, sales, distribution, and use, establishing credit records, publicizing serious untrustworthy information in accordance with regulations, and implementing joint punishments , law to take seizure, detention and other measures, ordered the recall as well as supervision and inspection, licensing, and other penalties
.
The Vaccine Management Law requires the government and its relevant departments to strengthen supervision and protection at the same time
.
For example, the government should include vaccine safety work and vaccination work into the national economic and social development plan at the same level, and include the necessary funds for vaccine safety work, the purchase of immunization plan vaccines and vaccination work, and information construction into the government budget at this level.
It stipulates that rural doctors and other primary-level medical and health personnel engaged in vaccination shall be subsidized, and vaccination shall be supported and subsidized in economically underdeveloped areas, and vaccination-related projects shall be determined and implemented in the administrative region
.
(2) Severe penalties and heavy penalties formed a deterrent to Changchun Changsheng's vaccine case, which exposed prominent problems such as low cost of illegal vaccine drugs and weak penalties
.
The Vaccine Management Law further embodies the "four most stringent" requirements, improves legal responsibilities, increases penalties for vaccine violations, increases the amount of fines, increases the types of penalties, strengthens the punishment to individuals, and supplements and perfects legal responsibilities for violations
.
The legal liability part of the Vaccine Management Law includes criminal liability, administrative liability, and civil liability.
There are 18 articles in total, accounting for nearly one-fifth of all articles.

.
Adhere to severe punishments and heavy penalties, and strictly enforce legal responsibilities
.
We will severely crack down on those illegal companies that are tempted by profit and ignore the rules, and those who dare to challenge the bottom line of morals and conscience, severely sentenced, and never tolerated; illegal criminals involved in vaccines and drugs that endanger public security will be severely punished in accordance with the law and implemented.
Huge penalties and life-long bans; serious accountability for dereliction of duty
.
The first is to clearly violate the provisions of this law and constitute a crime, and the criminal responsibility shall be investigated severely in accordance with the law
.
According to the principle of statutory crimes and punishments, criminal responsibility is usually uniformly stipulated by the criminal law
.
The administrative law's provisions on criminal responsibility are usually cohesive, expressed as "violating the provisions of this law and constituting a crime, criminal responsibility shall be investigated in accordance with the law
.
" During the legislative process, some proposed that for illegal activities such as the production of counterfeit and inferior vaccines, in addition to stipulating more severe administrative penalties than general drug violations, if a crime is constituted, criminal responsibility should be investigated in accordance with the law, embodying the "four most stringent.
" Spirit
.
In fact, there is already a basis for criminal justice practice to pursue criminal responsibility for some vaccine crimes
.
Articles 141 and 142 of the Criminal Law stipulate the crime of producing and selling counterfeit and inferior medicines
.
The "Interpretation on Several Issues Concerning the Application of Laws in Handling Criminal Cases Endangering Drug Safety" stipulates that if the counterfeit and inferior drugs produced and sold are vaccines, they shall be punished severely as appropriate
.
On the basis of judicial interpretations, the Vaccine Management Law makes it a statutory requirement that the criminal responsibility of vaccine-related crimes is heavily investigated
.
The second is to implement the most severe punishment
.
For illegal activities such as the production and sale of fake and inferior vaccines, and data falsification, warnings and huge fines are provided (for example, for the production and sale of fake vaccines, a fine of 15 times to 50 times the value of the illegal production and sale of vaccines; If the amount is less than 500,000 yuan, it will be calculated at 500,000 yuan, that is, a minimum fine of 7.
5 million yuan), confiscation of illegal income, confiscation of illegal property, order to suspend production and business for rectification, and revoke batch issuance certificates, drug registration certificates, drug production licenses, etc.
Punishment
.
Implement the requirements for punishment to persons, and stipulate the confiscation of income, fines, prohibition of employment until life ban, suspension of practice, and suspension of legal representatives, main persons in charge, directly responsible persons in charge, personnel in key positions and other responsible persons of illegal units Practicing certificate, administrative detention and other punishments
.
The type of administrative penalties covering honorary penalty, property penalty, penalty qualifications, behavior and punishment, physical punishment and so on
.
In January 2020, the Administrative Punishment Law was revised and passed, and relevant parties must implement administrative punishments in accordance with the spirit and requirements of the revised Administrative Punishment Law
.
The third is to uphold the most serious accountability
.
Local governments at or above the county level, their drug regulatory departments, health and health departments, etc.
, batch issuing agencies, disease control agencies, etc.
, have violated laws, such as failing to perform their supervision and inspection duties, illegally issuing batches, and failing to purchase vaccines in accordance with regulations.
The main person in charge, the directly responsible person in charge, and other directly responsible persons stipulate the sanctions from warning to expulsion in accordance with the law
.
In addition, the Vaccine Management Law also stipulates the civil compensation liability of vaccine marketing license holders, disease control agencies, and vaccination units, and clarifies that the country implements a mandatory vaccine liability insurance system.
If the vaccine quality issues cause damage to the victim, insurance The company pays compensation within the underwriting liability limit
.
7.
Perseverance, the vitality of thoroughly implementing the law lies in the implementation, and the authority of the law also lies in the implementation
.
Since the implementation of the Vaccine Management Law, especially since the outbreak of the new crown pneumonia epidemic, all parties have actively and thoroughly implemented the laws and regulations, the safety of vaccines has been effectively guaranteed, and the healthy development of the vaccine industry has achieved remarkable results
.
At present, the prevention and control of the new crown pneumonia epidemic has achieved major strategic results, but it is still necessary to do a good job of "foreign defense import and internal defense rebound"; the task of prevention and control of infectious diseases in my country is still very arduous.
According to the official website of the National Health Commission, In December 2020, a total of 542,172 cases of notifiable infectious diseases were reported nationwide, with 2379 deaths.
Among them, a total of 264,109 cases of type B infectious diseases were reported, and 2,377 deaths were reported.
The top 5 reported cases were viral hepatitis, Tuberculosis, syphilis, gonorrhea and AIDS
.
We must always adhere to the people first and life first, continue to implement the vaccine management law, strengthen and improve vaccine management, promote the prevention and control of the new crown pneumonia epidemic and other infectious diseases on the track of the rule of law, and earnestly safeguard people’s health and public health Safe
.
The first is to advance the development, production, supply, and vaccination of vaccines in accordance with the law to provide powerful weapons for the ultimate victory over the new crown pneumonia epidemic and other infectious diseases
.
At present, the new coronary pneumonia vaccines that are conditionally approved for marketing still need to carry out post-marketing research in accordance with the law, and the new coronary pneumonia virus is still mutating and needs to be developed in a targeted manner
.
The production of the new crown pneumonia vaccine to meet domestic and foreign needs, and the establishment of an immune barrier to protect the whole people by vaccination, there are still arduous tasks, and there are still some bottlenecks in the production and supply of other vaccines
.
Promoting vaccine development, production, supply, and vaccination in accordance with the law has a long way to go
.
The Vaccine Management Law clarifies the duties and obligations of the government and its related departments and parties
.
The government and its relevant departments must insist that the law is not authorized, and the statutory duties must be fulfilled.
The statutory duties must be fully performed.
The role of the inter-ministerial joint conference system for vaccine management must be brought into full play.
Authoritative vaccine supervision and guarantee system
.
Vaccine marketing license holders, disease control agencies, vaccination units, and other relevant entities must fully fulfill their statutory obligations and do a good job of vaccine development, production, supply, and vaccination in accordance with the law with high quality and efficiency
.
At present, the new crown pneumonia epidemic is still raging around the world
.
The Vaccine Management Law stipulates that the state encourages vaccine manufacturers to produce and export vaccines in accordance with international procurement requirements; the exported vaccines should meet the standards or contract requirements of the importing country (region), and arrangements have been made for entry and exit vaccinations and the procurement of required vaccines.

.
Viruses know no borders, epidemics do not distinguish between races, human destiny is a community, solidarity and cooperation are the most powerful weapons to respond to global public health emergencies, we must uphold the concept of a human health community, and strengthen international vaccine cooperation and care in accordance with the provisions of the Vaccine Management Law.
All human health
.
Vaccine business is an important part of health business, especially public health business
.
It is necessary to thoroughly implement the decision and deployment of the Party Central Committee, improve the disease prevention and control system, strengthen and improve the publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response, etc.
of the disease control institution and vaccination, and strengthen vaccine supervision Build capacity and other aspects, prevent vaccine safety incidents, and vigorously develop the vaccine business
.
The second is to adhere to social co-governance, benign interaction, and cohesion
.
Social co-governance is a new initiative to innovate social management.
Strengthening vaccine management is a systematic project.
We must fully mobilize all sectors of society to participate and give play to the positive role of social co-governance
.
The Vaccine Management Law clearly stipulates the systems of information disclosure, information sharing, information exchange and communication, and unified information announcement to facilitate public access to information and in-depth participation in vaccine management activities; stipulates reporting rewards, media supervision, social supervision, etc.
, to strengthen public participation; The China Vaccine Industry Association is required to strengthen industry self-discipline, establish and improve industry standards, promote the construction of an industry credit system, and guide and urge members to carry out production and operation activities in accordance with the law
.
The government and its related departments, disease control agencies, vaccination units, vaccine marketing license holders, vaccine industry associations and other relevant parties shall carry out publicity, education, and popularization of the vaccine legal system in accordance with the law
.
In the initial stage of the new crown pneumonia vaccine market, individual criminals took advantage of the temporary supply of scarce supplies to get their hearts out.
They made huge profits through counterfeit sales, high-priced reselling, illegal operations in violation of national regulations, and group vaccinations without authorization, and some even used fake vaccines.
Smuggling abroad seriously disrupts the order of epidemic prevention, endangers people’s health and public health safety, and corrupts the country’s image.
This type of criminal behavior is bad in nature and has serious consequences
.
As of February 10, 2021, procuratorial organs across the country have legally approved the arrest of 70 suspects in 21 cases
.
Relevant parties must strictly implement the provisions of the Vaccine Management Law, increase law enforcement, and severely punish vaccine violations
.
The third is to carefully evaluate the implementation of the Vaccine Management Law and strengthen the legal protection of public health
.
Since the outbreak of the new crown pneumonia, the Vaccine Management Law has undergone practical tests, proving that the system prescribed by the Vaccine Management Law is scientifically effective and forward-looking
.
General Secretary Xi Jinping emphasized that it is necessary to conscientiously summarize the experience and models tested in practice in the prevention and control of the epidemic, and solidify it in the form of a system
.
[9] The "Work Plan of the 13th National People's Congress Standing Committee to Strengthen Public Health Legal Protection Legislation Amendment" proposed that the vaccine management law and other public health-related legislative projects should be carried out in conjunction with epidemic prevention and control and a sound public health emergency management system.
In-depth evaluation, after research and demonstration, is necessary and feasible, adopt various forms, make targeted amendments, and arrange deliberation in a timely manner
.
In accordance with the spirit of General Secretary Xi Jinping’s important instructions and the requirements of the 13th National People’s Congress Standing Committee Strengthening Public Health Legal Protection Legislation Work Plan, we must conscientiously summarize the epidemic prevention and control experience, thoroughly evaluate the implementation of the vaccine management law, and provide timely evaluation opinions
.
Based on the formation of a comprehensive, scientific, standardized, and effective vaccine management legal system, a supporting system needs to be filled and detailed, and continue to promote the formulation and improvement of supporting laws, regulations, standards, and specifications, and integrate the principles and generalizations of the vaccine management law.
The specific provisions of the vaccine management law ensure that the various systems stipulated by the Vaccine Management Law take root and are effectively implemented
.
In the prevention and control of the new crown pneumonia epidemic, vaccines, especially the new crown pneumonia vaccine development, production, supply, vaccination, and other work practices have enriched and developed a vaccine management system.
The vaccine management experience and model that have been tested in practice need to be consolidated in the form of a legal system.
, It is necessary to promptly put forward suggestions for amending the vaccine management law
.
The promulgation and implementation of the Vaccine Management Law has promoted major new achievements in China's vaccine industry and even the health industry
.
Persevere and persevere in the complete, accurate, comprehensive and effective implementation of the vaccine management law, use the vaccine management law to promote vaccine development, deal with and solve the problems in vaccine production, distribution, and vaccination, and consolidate and expand the epidemic prevention and control and economic society in accordance with the law.
Development results, safeguarding people’s health and public health safety, and comprehensively promoting the construction of a healthy China
.